Back to resultsStudy Evaluating the Effect of Lecozotan SR on the QTc Interval
Primary Purpose
Alzheimer Disease, Healthy
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Lecozotan SR
Moxifloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Healthy Subjects
Eligibility Criteria
Inclusion Criteria:
- Women and men aged 18 to 55 years inclusive.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
Exclusion Criteria:
- History of any clinically important drug allergy.
- Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).
Sites / Locations
Outcomes
Primary Outcome Measures
To assess the effect of drug administration on QTc interval.
Secondary Outcome Measures
Full Information
NCT ID
NCT00499642
First Posted
July 10, 2007
Last Updated
December 19, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00499642
Brief Title
Study Evaluating the Effect of Lecozotan SR on the QTc Interval
Official Title
A Single-Dose, Double-Blind, Crossover, Placebo- and Moxifloxacin (Open-Label)-Controlled Study of the Effects of Lecozotan SR on Cardiac Repolarization in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled, 4-period crossover study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Healthy
Keywords
Healthy Subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lecozotan SR
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Primary Outcome Measure Information:
Title
To assess the effect of drug administration on QTc interval.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women and men aged 18 to 55 years inclusive.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
Exclusion Criteria:
History of any clinically important drug allergy.
Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For France: infomedfrance@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Rennes
ZIP/Postal Code
35000
Country
France
City
Rueil-Malmaison
ZIP/Postal Code
92502
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Effect of Lecozotan SR on the QTc Interval
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